Abstract

BIOANALYTICAL METHOD DEVELOPMENT AND VALIDATION: OVERVIEW

Pradip Todkar* and Dr. Purnima D. Hamrapurkar

Abstract

Bioanalytical method used for the analysis of analytes and their metabolite, endogenous compound and biomarker from biological fluid. The method are clinical and non-clinical toxicokinetic and pharmacokinetic studies to evaluate the efficacy and safety of drug. Bioanalytical method evaluating of characteristics such as in vivo bioavailability, bioequivalence and drug-drug interaction. In this manuscript review article paper focus on the bioanalytical method development, validation parameter and Good laboratory practices is discussed selectivity, sensitivity, cross selectivity, matrix effect, calibration curve, accuracy, precision, stability, reinjection reproducibility, hemolysis effect, batch size determination. Bioanalytical studies divided into method development, method validation and sample analyzed under the guidance of laboratory practice standard.

Keywords: bioanalytical, method validation, precision, accuracy, sensitivity, selectivity, reproducibility, GLP.